ATOZET10 MG40 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

ATORVASTATIN AS CALCIUM TRIHYDRATE; EZETIMIBE

Available from:

ORGANON PHARMA ISRAEL LTD., ISRAEL

ATC code:

C10BA05

Pharmaceutical form:

FILM COATED TABLETS

Composition:

ATORVASTATIN AS CALCIUM TRIHYDRATE 40 MG; EZETIMIBE 10 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

ORGANON LLC, USA

Therapeutic area:

ATORVASTATIN AND EZETIMIBE

Therapeutic indications:

- Prevention of Cardiovascular EventsAtozet is indicated to reduce the risk of cardiovascular events in patients with coronary heart disease (CHD) and a history of acute coronary syndrome (ACS), either previously treated with a statin or not.- HypercholesterolaemiaAtozet is indicated as adjunctive therapy to diet for use in adults with primary (heterozygous familial and non-familial) hypercholesterolaemia or mixed hyperlipidaemia where use of a combination product is appropriate• patients not appropriately controlled with a statin alone• patients already treated with a statin and ezetimibe- Homozygous Familial Hypercholesterolaemia (HoFH)Atozet is indicated as adjunctive therapy to diet for use in adults with HoFH. Patients may also receive adjunctive treatments (e.g., low-density lipoprotein [LDL] apheresis).

Authorization date:

2021-06-30

Patient Information leaflet

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS REGULATIONS
(PREPARATIONS) 1986
This medicine is marketed upon doctor's prescription only
ATOZET
® 10 MG/10 MG
ATOZET
® 10 MG/20 MG
ATOZET
® 10 MG/40 MG
ATOZET
® 10 MG/80 MG
FILM-COATED TABLETS
Each film-coated tablet contains:
Ezetimibe 10 mg and atorvastatin (as calcium trihydrate) 10 mg, 20 mg,
40 mg or 80 mg.
For a list of inactive ingredients see section 6 "Further
information". See also section 2.8, “Important
information about some of the ingredients of ATOZET”.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
•
This leaflet contains concise information about ATOZET. If you have
any further questions, ask your
doctor or pharmacist.
•
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if their
medical condition seems similar to yours.
•
ATOZET is intended for treatment of adults above 18 years of age.
1. WHAT ATOZET IS INTENDED FOR?
ATOZET is used in combination with a diet,
•
for the treatment of primary hypercholesterolaemia [heterozygous
familial and non-familial] or to
decrease elevated fat levels in the blood (mixed hyperlipidaemia) in
adult patients:
•
that are not well controlled with a statin alone; or
•
are already treated with statin and ezetimibe
•
for the treatment of adult patients with a hereditary illness
(homozygous familial
hypercholesterolaemia). The treatment may be given in combination with
other treatments.
•
If you have heart disease, to reduce the risk of cardiovascular events
(as heart attack, stroke, surgery
to increase heart blood flow, or hospitalisation for chest pain).
THERAPEUTIC GROUP: Ezetimibe belongs to a group of medicines called
_CAI_ (Cholesterol absorption
Inhibitors),
which inhibits the intestinal absorption of cholesterol. Atorvastatin
belongs to a group of medicines
called statins, which are HMG-CoA reductase enzyme inhibitors.
ATOZET works to reduce your cholesterol in two ways. It reduces
cholesterol absorption in yo

Summary of Product characteristics

1.
NAME OF THE MEDICINAL PRODUCT
ATOZET® 10 mg/10 mg
ATOZET® 10 mg/20 mg
ATOZET® 10 mg/40 mg
ATOZET® 10 mg/80 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 10 mg of ezetimibe and 10, 20, 40 or
80 mg of atorvastatin (as
atorvastatin calcium trihydrate).
Excipient(s) with known effect
Each 10 mg/10 mg film-coated tablet contains 153 mg of lactose.
Each 10 mg/20 mg film-coated tablet contains 179 mg of lactose.
Each 10 mg/40 mg film-coated tablet contains 230 mg of lactose.
Each 10 mg/80 mg film-coated tablet contains 334 mg of lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
10 mg/10 mg tablet: Capsule-shaped, biconvex, white to off-white,
film-coated, size 12.74 mm x
5.10 mm, “257” debossed on one side
10 mg/20 mg tablet: Capsule-shaped, biconvex, white to off-white,
film-coated, size 14.48 mm x
5.79 mm, “333” debossed on one side
10 mg/40 mg tablet: Capsule-shaped, biconvex, white to off-white,
film-coated, size 16.38 mm x
6.27 mm, “337” debossed on one side
10 mg/80 mg tablet: Capsule-shaped, biconvex, white to off-white,
film-coated, size 19.05 mm x
7.94 mm, “357” debossed on one side
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_Prevention of Cardiovascular Events _
ATOZET is indicated to reduce the risk of cardiovascular events (see
section 5.1) in patients with
coronary heart disease (CHD) and a history of acute coronary syndrome
(ACS), either previously
treated with a statin or not.
_Hypercholesterolaemia _
ATOZET is indicated as adjunctive therapy to diet for use in adults
with primary (heterozygous
familial and non-familial) hypercholesterolaemia or mixed
hyperlipidaemia where use of a
combination product is appropriate.
•
patients not appropriately controlled with a statin alone
•
patients already treated with a statin and ezetimibe
_Homozygous Familial Hypercholesterolaemia (HoFH) _
2
ATOZET is indicated as adjunctive therapy to diet for use in adults
with HoFH. Patients may also
receive